A Study of the Efficacy and Safety of Alteplase in Participants With Mild Stroke

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Stroke

In brief

PRISMS is a double-blind, multicenter, randomized, Phase IIIb study to evaluate the efficacy and safety of intravenous (IV) alteplase in participants with mild acute ischemic strokes that do not appear to be clearly disabling. Participants will be randomized in a 1:1 ratio to receive within 3 hours of last known well time either 1) one dose of IV alteplase and one dose of oral aspirin placebo or 2) one dose of IV alteplase placebo and one dose of oral aspirin 325 milligrams (mg).

Key facts

Study ID

NCT02072226

Run by

Genentech, Inc.

People needed

313

Starts

2014-05-31

Expected to finish

2017-03-22

Last updated by the study team

2018-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Mild ischemic stroke defined as the most recent pre-treatment NIHSS score of less than or equal to(</=) 5 and determined as not clearly disabling by the investigator
• Study treatment initiated within 3 hours of last time participant seen normal

You may not qualify if…

• Computed tomography (CT) or magnetic resonance imaging (MRI) findings of one of the following:
• CT with clear large hypodensity that is greater than (>) one-third middle cerebral artery (MCA) territory (or >100 cubic centimeter [cc] if not in MCA territory)
• MRI with clear large hyperintensity on concurrent diffusion-weighted (DW) and fluid-attenuated inversion recovery (FLAIR) that is greater than one-third MCA territory (or greater than 100 cc if not in MCA territory),
• Imaging lesion consistent with acute hemorrhage, or
• Evidence of intraparenchymal tumor
• Disability prior to the presenting stroke
• Standard contraindications to IV alteplase within 3 hours of symptom onset, including:
• Head trauma, myocardial infarction, or previous stroke within the previous 3 months
• Gastrointestinal or urinary tract hemorrhage within the previous 21 days
• Major surgery within the previous 14 days
• Arterial puncture at non-compressible site within the previous 7 days
• Any history of ICH with the exception of those less than (<) 5 chronic microbleeds on MRI
• Elevated blood pressure defined by systolic blood pressure >185 millimeters of mercury (mm Hg) or diastolic blood pressure >110 mm Hg, or treatments requiring aggressive measures to achieve acceptable levels
• Treatment with unfractioned heparin within past 48 hours and activated partial thromboplastin time outside normal range
• Blood glucose <50 milligrams per deciliter (mg/dL)
• International normalized ratio >1.7
• Platelet count <100,000 per cubic millimeter (/mm\^3)
• Treatment with a direct thrombin inhibitor (dabigatran) or a factor Xa inhibitor (apixaban, rivaroxaban, edoxaban) within the last 48 hours
• Allergic reaction to study drug, aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs)
• Females of childbearing age who are known to be pregnant and/or lactating
• Inability to swallow, which would prevent oral intake of aspirin or aspirin placebo tablet
• Other serious, advanced, or terminal illness that would confound the clinical outcome at 90 days
• Current or recent (within 3 months) participation in another investigational drug treatment protocol
• Anticipated inability to obtain 3-month follow-up assessments
• Previous enrollment in PRISMS

Where it is running

• Banner Good Samaritan Medical Center — Phoenix, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• St. Jude Medical Center — Fullerton, California, United States
• University of California San Diego — La Jolla, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Hoag Memorial Hospital — Newport Beach, California, United States
• University of California Los Angeles — Santa Monica, California, United States
• Colorado Neurological Institute — Englewood, Colorado, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Medical Center of The Rockies — Loveland, Colorado, United States
• Associated Neurologists PC — Danbury, Connecticut, United States
• Associated Neurologists of Southern CT PC — Fairfield, Connecticut, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Christiana Care Health Services; Sponsor Programs Ammon Education Center — Newark, Delaware, United States
• Nova Clinical Research, LLC — Bradenton, Florida, United States
• Neurologic Consultants, P.A. — Fort Lauderdale, Florida, United States
• University of Miami Miller School of Medicine; Clinical Reseach Building — Miami, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Alexian Brothers Neuroscience Institute — Elk Grove Village, Illinois, United States
• Parkview Research Center — Fort Wayne, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• St. Elizabeth Edgewood; Cancer Care Center" for Account St. Elizabeth Edgewood — Edgewood, Kentucky, United States
• University of Louisville — Elizabethtown, Kentucky, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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